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Better Asthma Outcomes: Lowering Tobacco Smoke Exposure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00217958
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : October 28, 2014
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Palo Alto Medical Foundation

Study Description
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Brief Summary:
To improve disease outcomes through reduction in secondhand tobacco smoke exposure of children with asthma

Condition or disease Intervention/treatment Phase
Lung Diseases Asthma Behavioral: SHS reduction intervention based on social cognitive learning theory Not Applicable

Detailed Description:

BACKGROUND:

Secondhand tobacco smoke (SHS) exposure increases asthma morbidity in children. Efforts to reduce exposure have had mixed results. This study is a randomized controlled trial of an exposure reduction intervention, with objective feedback to parents on the child's exposure based on urine cotinine measurement, and counseling tailored to the child's specific exposure sources/locations and parental readiness to take specific actions to reduce exposure from each source/location. This trial involves 350 SHS-exposed children with persistent asthma, 3-12 years of age, receiving care from the Kaiser Health Care Program in Northern California. Primary outcomes over the 18 months of follow-up will be asthma acute care utilization and urine cotinine/creatine ratio. Changes in controller medication adherence will be evaluated using a pharmacy-based dispensing index.

DESIGN NARRATIVE:

Primary objective: To evaluate the efficacy of a behaviorally-based, cotinine-feedback-and-monitoring program designed to reduce SHS exposure in an 18-month randomized controlled trial (RCT) with 350 children with persistent asthma, 3-12 years of age, in comparison with usual medical care.

Secondary objectives: 1) to investigate the behavioral mechanisms that mediate between the intervention and associated improvements in asthma outcomes, and 2) to determine the influence of initial caregiver stage of change with regard to smoking practices on response to the intervention.

Hypotheses:

  1. Disease outcomes: A behaviorally-based, individually-tailored intervention that emphasizes SHS exposure reduction, provides sequential feedback to the parent on the child's urine cotinine level, and is tailored to the parent's stage of change with regard to smoking practices will be associated with decreased asthma crisis care utilization and improvements in secondary disease outcomes over an 18-month follow-up period when compared with usual medical care.
  2. ETS exposure: The SHS reduction intervention will be associated with lower SHS exposure at follow-up (assessed by urine cotinine/creatinine ratio), compared with usual medical care.
  3. Mechanism: Decreases in urine cotinine/creatinine ratio will be instrumental in intervention-associated improvements in asthma crisis care utilization.
Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Study Start Date : May 2002
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Age 3-12 years
  • Kaiser member for >= 1 year
  • >= 1 asthma care visit in prior year
  • Persistent asthma likely based on prior year:

Physician diagnosis code of persistent asthma OR >= 4 beta agonist (BA) dispensing events OR >= 4 Anti-inflammatory (AI) dispensing events

  • Secondhand smoke exposure by parent report.
  • Parent agrees to participate in a clinical trial of a smoke exposure reduction interventio
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00217958


Sponsors and Collaborators
Palo Alto Medical Foundation
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Sandra Wilson Res Inst, Palo Alto Med Fdn
More Information
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Publications:
Farber HJ, Wilson SR, Caine L, Bertorello L, Brown NL, Verghese S, Luna V, Quesenberry CP. Association between parent report of smoke exposure level, effect of smoke on child's asthma, and urine cotinine levels. Paper presented at the 2005 Annual Meeting of the American Thoracic Society, San Diago, CA, May 24, 2005. Proceedings of the American Thoracic Society; Vol.2 Abstracts Issue; 2005.
Wilson SR, Brown NL, Farber HJ, Luna V, Verghese S, Caine L, Bertorello L, Quesenberry CP. Sources of and caregiver readiness to reduce secondhand smoke (SHS) exposure of children with asthma. Poster presented at the 2005 Annual Meeting of the American Thoracic Society, San Diago, CA, May 24, 2005. Proceedings of the American Thoracic Society; Vol.2 Abstracts Issue; 2005.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Palo Alto Medical Foundation
ClinicalTrials.gov Identifier: NCT00217958    
Other Study ID Numbers: 295
R01HL070012 ( U.S. NIH Grant/Contract )
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: October 28, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Asthma
Lung Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases